Medical device business license
Medical Device Business License is a necessary document for medical device business enterprises. The establishment of a class I medical device trading enterprise shall be filed with the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government. The establishment of Class II and Class III medical device trading enterprises shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government, and a License for Medical Device Trading Enterprises shall be issued. Without the Medical Device Business License, the administrative department for industry and commerce shall not issue a business license. The validity period of the Medical Device Business Enterprise License is 5 years.
Licensing of medical device business enterprises
Contents of administrative license:
1. Review and issue the newly established Business License for Medical Devices (Class II and Class III medical devices).
2, the second and third types of medical device business enterprises merger, division or migration across the original jurisdiction.
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices;
2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1, the legal representative of the enterprise, the person in charge of the enterprise, and the quality management personnel shall not have the circumstances specified in Article 40 of the Regulations on the Supervision and Administration of Medical Devices;
2. An enterprise shall have a quality management organization or full-time quality management personnel suitable for its business scale and scope; Quality management personnel should have relevant professional qualifications or titles recognized by the state, and have professional and technical personnel who have obtained qualifications according to law. If the quality manager should be at work, not in other units.
3. It has a relatively independent business place suitable for its business scale and scope.
4. Having storage conditions (storage equipment and facilities) suitable for the business scale and scope.
5. Ability to provide technical training and after-sales service for products.
6, should according to the relevant provisions of the state and local, establish and improve the necessary quality management system, and strictly enforced.
7, should collect and save the national standards, industry standards and regulations, rules and special provisions of the supervision and management of medical devices.
8, in accordance with the "Guangdong Province set up medical device business enterprise acceptance implementation standards" for acceptance.
List of materials submitted by the applicant:
1. Medical device business license and medical device business license application form.
2. Notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce.
3. Application report.
4. Proof documents of the business premises and storage premises, including the copy of the title certificate or lease agreement and the title certificate of the lessor.
5, business premises, warehouse layout.
6. Copy of ID card, diploma or title certificate of the person in charge, the person in charge of the enterprise and the quality manager and their resumes.
7. List of technical personnel and copies of academic qualifications and professional title certificates.
8, management quality management standard file directory.
9. The enterprise has installed the product invoicing information management system and printed the homepage of the information management system.
10, storage facilities and equipment directory.
1 1. On-the-job self-assurance statement of the quality management personnel and the self-assurance statement of the authenticity of the application materials, including the catalogue of the application materials and the enterprise's commitment to bear legal responsibility for any falsehood;
12. When applying for enterprise application materials, if the person in charge is not the legal representative or the person in charge, the enterprise shall submit a power of attorney.
13, application for medical device business license confirmation
Requirements for application materials:
1. The Application Form for Medical Device Business License submitted by the business enterprise shall be signed by the legal representative or stamped with the official seal of the enterprise;
2, the medical device business license application form to fill in the project should be complete and accurate, fill in the content should meet the following requirements.
The "enterprise name" and "registered address" are the same as the industrial and commercial business license or the notice of pre-approval of enterprise name.
B the business scope for application shall be filled in according to the Class I Catalogue of Medical Devices issued by the State Medical Device Administration in 2002.
C, "registered address" and "warehouse address" should fill in the specific house number, floor and room number.
3. The identity certificate, education certificate, professional title and appointment document of the legal representative shall be valid;
4, issued by the administrative department for Industry and commerce "enterprise name pre-approval notice" or "business license" copy should be the same as the original, copy confirmed retained, the original returned;
5. Real estate license and house lease certificate (the lessor needs to provide * * *) are valid;
6, the person in charge of the enterprise, the quality manager's resume, diploma or title certificate should be within the validity period;
7, enterprises should establish medical device quality management documents or forms according to their own reality.
8. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise. If there is no official seal, it shall be signed or sealed by the legal representative himself.
9. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit; Individual applications should be signed or sealed.
10. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be typed and filled in by computer, printed on A4 paper, copied on A4 paper, and bound in the order of application materials.
Legal liability:
1. If the applicant conceals relevant information or provides false materials to apply for the Medical Device Business License, the food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government or the entrusted food and drug supervision and administration institutions of cities with districts will not accept the application or issue the Medical Device Business License and give a warning. The applicant shall not apply for the Medical Device Business License again within 1 year.
2. If the applicant obtains the medical device business license by cheating, bribery or other improper means, the (food) drug supervision and administration department shall revoke its medical device business license, give a warning and impose a fine of 6,543,800 yuan to 20,000 yuan. The applicant shall not apply for a medical device business license again within 3 years.
Examination and approval of license change of medical device business enterprise
Contents of administrative license:
Examining and approving the License for Medical Device Business Enterprises (Class II and Class III Medical Devices) and changing the name, legal representative, person in charge, person in charge of quality, registered address, warehouse address and business scope of the enterprise.
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices;
2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1. Enterprises that have obtained the Medical Device Enterprise License within the administrative region of this province;
2, in line with the "medical device business license management measures" and "provincial medical device business enterprise acceptance implementation standards (revised in 2007)" requirements. Apply for changing the relevant provisions of the enterprise name, legal representative, person in charge, quality manager, registered address, warehouse address and business scope.
List of materials submitted by the applicant:
1. Application Form for Medical Device Business License and Change of Medical Device Business License;
2. The original and copy of the medical device enterprise license;
3. A copy of the business license;
4 quality manager's ID card, diploma or title certificate copy and resume. On-the-job certification materials.
5, the enterprise intends to change the content of the situation;
(1) If the legal representative of the enterprise changes, submit: the identity certificate, education certificate or professional title certificate of the legal representative, 1 job resume and the original business license after the change;
(2) If the person in charge of the enterprise changes, it shall submit the identity certificate, education certificate or professional title certificate, copy of employment documents and work resume of the person in charge of the enterprise;
(3) Where the name of an enterprise is changed, the Notice of Approval for Change of Enterprise Name issued by the administrative department for industry and commerce and the original business license after the change shall be submitted;
(4) If the registered (business) address of the enterprise changes, provide the floor plan of the business place, the property right or use certificate of the house, and the geographical location map.
(5) If the address of the warehouse is changed, it is necessary to provide the layout of the warehouse, the property right or use certificate of the house, the geographical location map and the catalogue of warehouse facilities and equipment.
To operate in vitro diagnostic reagents, it shall provide relevant cold chain facilities certification materials. Such as standby generator set or standby refrigeration set, automatic temperature controller, automatic alarm equipment, refrigerated truck and other invoices, cold storage installation contract, operation qualification certificate, etc.
(6) If the business scope changes, it is necessary to provide warehouse layout, house property right or use certificate, warehouse facilities and equipment catalogue and description of corresponding storage conditions, copy of quality manager's education or title certificate, list of professional and technical personnel, copy of education, title certificate, ID card, registration certificate and description of corresponding storage conditions.
(7) If the quality manager is changed, it is necessary to provide the education background, professional title certificate, copy of ID card and resume of the enterprise quality manager.
6, quality management personnel on-the-job self-assurance statement; A self-assurance statement on the authenticity of the application materials, including the catalogue of the application materials and the enterprise's commitment to bear legal responsibility for the falsehood of the materials;
7. When applying for enterprise application materials, if the handling personnel are not legal representatives or responsible persons, the enterprise shall submit a power of attorney.
8, change the "medical device business license" confirmation.
Eight, the requirements of the application materials:
1. The Application Form for Change of Medical Device Business License submitted by the business enterprise shall be signed by the legal representative and stamped with the official seal;
2, the medical device business license change application form to fill in the project should be complete and accurate, fill in the content should meet the following requirements:
(1) The "enterprise name" and "registered address" are the same as those in the Business License for Industry and Commerce or the Notice of Pre-approval of Enterprise Name Change;
(2) Fill in the specific house number, floor number and room number in the "registered address" and "warehouse address".
3, the legal representative's identity certificate, education certificate or title certificate, employment documents should be valid;
4. A copy of the Notice of Pre-approval of Enterprise Name Change or the Industrial and Commercial Business License shall be consistent with the original. Copy confirmed retained, the original returned;
5. The self-assurance statement of the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise.
6. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit.
7. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be printed and filled out by computer, printed on A4 paper, copied on A4 paper, and bound into volumes according to the order of application materials.
Examination and approval of renewal of medical device business enterprises
Contents of administrative license:
Supplementary certificate of medical device business license (Class II and Class III medical devices)
Legal basis for setting license:
1, Regulations on the Supervision and Administration of Medical Devices;
2. Measures for the administration of licenses of medical device enterprises
Administrative licensing conditions:
1. Enterprises that have obtained the Medical Device Enterprise License within the administrative region of this province;
2. If the Medical Device Business License is lost or damaged, you can apply for a replacement certificate.
3. The applicant applies to the provincial US Food and Drug Administration for a replacement certificate 25 days after the announcement of the loss reporting statement.
Seven. List of materials submitted by the applicant:
1. Application form for supplementary certificate of medical device business license, application report or explanation, and electronic declaration document of medical device business license.
2. The original loss statement published in Nanfang Daily;
3. Copy of business license
4. A self-assurance statement on the authenticity of the application materials, including the enterprise's commitment to bear legal responsibility for the falsehood of the materials.
5. If the applicant is not the legal representative or person in charge when the enterprise applies for the materials, the enterprise shall submit a power of attorney.
Requirements for application materials:
1. Check the Application Form for Supplementary License of Medical Device Business Enterprises submitted by the business enterprise, which shall be signed by the legal representative and stamped with the official seal;
2. The items filled in the Application Form for Supplementary License for Medical Device Business Enterprises should be complete and accurate, and the contents should meet the following requirements: the name of the business enterprise, the address of the registered (business) warehouse, and the legal representative are consistent with the original License for Medical Device Business Enterprises;
3. Consult the original and photocopy of Nanfang Daily which published the lost statement, confirm the photocopy and return the original;
4. Twenty-five days have elapsed since the date when the enterprise filed the application and the loss statement was published;
5. The self-assurance statement to verify the authenticity of the application materials shall be signed by the legal representative and stamped with the official seal of the enterprise.
6. If the application materials need to be copied, the applicant (unit) shall indicate the words "this copy is consistent with the original" or a written explanation on the copy, indicate the date and affix the official seal of the unit.
7. The application materials shall be complete, clear, signed and stamped with official seals one by one. All application forms should be printed and filled out by computer, printed on A4 paper, copied on A4 paper, and bound into volumes according to the order of application materials.
To operate contact lenses, you need to apply to the Food and Drug Administration for a medical device business license. The materials you need to prepare are a copy of business license or industrial and commercial inspection notice, office space and warehouse contract, real estate license or goods sales lease contract, personnel information (ID card, education certificate. Resume) Business scope.
The above information is provided by Gai Shi Jun Bao.
Does contact lens care solution need a medical device business license? Contact lens care solution belongs to the third category of medical devices. If you operate, you must apply for a medical device business license, otherwise it will be dealt with as unlicensed operation, and not only all the products it operates will be confiscated, but also the illegal income will be confiscated. If the illegal income is less than 6,543,800 yuan, a fine of 50,000 yuan to 6,543,800 yuan shall be imposed. If it exceeds 10000 yuan, a fine of 10 to 20 times shall be imposed.
Handling of medical device business license I. Examination and approval authority
Enterprises dealing in Class II and Class III medical devices shall be submitted to the Provincial Drug Administration for examination and approval, and a Medical Device Business License shall be issued.
1, provincial enterprises (registered by the Provincial Administration for Industry and Commerce) are directly accepted by the Provincial Drug Administration;
2, other enterprises and units accepted by the municipal drug regulatory authorities and preliminary acceptance, qualified, write a written acceptance opinion and sign a preliminary examination opinion in the review form, reported to the provincial product supervision bureau for approval.
Second, the application materials:
1. Fill in the Application Form for Medical Device Business License in triplicate (the copy is invalid);
2. 1 application report;
3. Self-inspection summary of the enterprise (65,438+0 copies according to the requirements of "Detailed Rules for the Implementation of Qualification Identification of Medical Device Operating Enterprises in Guangdong Province" and "Guangdong Nuclear, Exchange and Acceptance Standards");
4. Articles of Association of the enterprise (company) and the latest capital verification report (providing the balance sheet and profit and loss statement of the replacement enterprise) each 1 copy;
5. 1 Certificate of property right or copy of lease agreement and floor plan of the business and storage place;
6. List of technical and maintenance personnel and copies of their graduation certificates and professional title certificates, each 1 copy (stamped with the official seal of the unit);
7. A copy of the detailed written preliminary acceptance report of the Municipal Drug Administration 1 (except for provincial enterprises);
8. Various management rules and regulations.
(1) quality responsibility and veto system,
(2) warehousing acceptance system, warehousing and outbound review,
(3) Quality analysis and feedback system,
(4) the validity management system,
(5) outlet sales quality management system,
(6) Management system for special and imported medical devices,
(7) After-sales service (installation, technical training, maintenance, repair, etc. ) system,
(8) Quality tracking and adverse reaction reporting system for implantable and special medical devices,
(nine) the reporting system and the health management system for the return, unqualified, expired and eliminated medical devices;
9. 1 name of enterprise: copy of industrial and commercial pre-registration certificate or business license of legal person;
10, self-assurance statement on the authenticity of the information provided.
Three. Approval procedure
1, only when the application materials are complete and meet the requirements of the examination and approval procedures can the provincial drug administration accept the application. The handler shall, within 15 working days from the date of acceptance, organize relevant personnel or entrust the municipal drug supervision department to conduct on-site acceptance in accordance with the Detailed Rules for the Implementation of Qualification Recognition of Medical Device Enterprises in Guangdong Province. The acceptance contents include: office, business, storage and maintenance places, inspection and maintenance records of equipment, installation and maintenance, implementation of quality system, on-the-job situation of technicians, laws and regulations on medical device business varieties and collection and preservation, quality standards for business varieties, medical device product registration certificates and other related materials.
2, on-site acceptance, 10 working days to fill in the "medical device approval form", put forward the preliminary examination opinions, according to the procedure submitted to the department, bureau leaders for approval.
Four. Requirements of application materials
1. The contents of the application report shall include: the economic nature of the enterprise, the introduction of the main person in charge, the establishment of departments, the establishment of branches, the main business areas and main sales targets, the main business varieties, specifications, storage places and surrounding environment, etc.
2. Plan of the business and storage place: The business and storage place shall be marked with the length, width (meter), business layout, shelf placement, fire fighting equipment, five prevention facilities, etc.
3. List of technicians and maintenance personnel: refers to scientific, medical, pharmaceutical and engineering technicians. Name, gender, age, graduate school, education, major, technical title, company position and ID number are required.
4. All application materials must be printed on A4 paper and stamped with the official seal of the enterprise, unit or superior competent unit. Copy of enterprise name, industrial and commercial pre-registration certificate or business license of enterprise as a legal person, graduation certificate of technical and maintenance personnel, professional title certificate, etc., and the reporting unit shall indicate the words "copy is consistent with the original" on the copy and affix the official seal, and bind it into volumes in sequence.
Verb (abbreviation for verb) Other matters
Enterprises and units shall declare according to the above-mentioned examination and approval procedures and requirements, and it is strictly forbidden to give property to the handling personnel. If you ask for or accept property, please report to the supervision office of the Provincial Drug Administration.
The Medical Device Business Enterprise License (Category III) applying for purchasing contact lenses refers to ophthalmologists, not optometrists. Generally, a college diploma is required. This certificate is more difficult. Just like an optometrist's license, you can go to the place where you apply for a senior optometrist's license and get contact lenses. It's good in Tianjin. You need a slit lamp, a keratometer and even a sink. I was there when my relatives used to do it. Actually, it's like semi-contact lenses. If you find their person in charge, just make it clear, otherwise they will make things difficult for you. If you do things well, he will do everything well for you. People in the Food and Drug Administration always deal with these things and know what to do. That's all for now. Good luck.
Medical device business license Medical device business license is the certificate of legal operation of medical device business enterprises.
Medical device business license requires the following information:
No. 1 Application Form for Medical Device Business License
No.2 Notice of Pre-approval of Enterprise Name
Data III. Self-inspection Form of Medical Device Enterprises (Wholesale) in Guangdong Province
Data 4. Plans and supporting documents of business premises and warehouse premises.
5. A copy of the ID card of the legal representative of the proposed enterprise.
No.6 information. ID card, diploma or title certificate copy and resume of the person-in-charge and quality manager of the proposed enterprise.
7. List of technical personnel and copies of academic qualifications and professional title certificates.
No.8, 1 management quality management standard document, including procurement, acceptance, warehousing, storage, quality tracking, user feedback, adverse event monitoring and quality accident reporting system;
Print the copy of the first page of the product invoicing information management system installed by the enterprise on the 9th.
Material number 10, storage facilities and equipment catalogue.
Data number 1 1, on-the-job self-assurance statement of quality management personnel and self-assurance statement of authenticity of application materials 1 copy, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood;
The material number is 12. If the applicant is not the legal representative or the person in charge, the enterprise shall submit 1 power of attorney.
MaterialNo. 13, Application for Medical Device Business License Confirmation
Our company can help enterprises to apply for medical device business license.
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Our company has a medical device business license. Can I operate contact lenses? No ~ ~ This needs hygiene approval ~ ~ ~
It doesn't cost much to apply for a medical device business license in an optical shop, and the agency fee in Beijing is 23 thousand, mainly because you have the actual business address.
Hello, Hunan, apply for a medical device business license. Since last year, almost all major provinces and cities in China have begun to make new adjustments to the declaration of medical device management companies.
Regarding whether there are corresponding requirements, any industry has some standards and policies. Medical device management also has relevant laws and regulations.
According to the new policy requirements issued by hunan food and drug administration last year (20110), the registered capital, personnel, office space and warehouse area are specified. For example, the minimum registered capital requirement for operating Class II medical device products is 500,000; The minimum registered capital requirement for operating Class II and Class III medical device products is 6,543.8+0,000, and the maximum is 6,543.8+0,000. This is because the registered capital will increase according to the number of three types of products; For example, the area requirements of offices and warehouses, the second-class medical equipment products are generally 160 square meters, and houses facing the street should be used for commercial and residential purposes. For example, offices and warehouses are no longer the same and need to be on the same plane or in the same community; For another example, the minimum area of office and warehouse for products of Class II and III is 200 square meters, and the maximum area can reach 500 square meters. The area requirements here are mainly related to the three types of products operated. As for the personnel requirements, the general quality supervisor requires a bachelor degree or above, and the full-time inspectors require a college degree or above. The specific major should be determined according to the products operated. But they usually choose from the following majors: clinical medicine, bioengineering technology, physics, electronics and so on.
As for time, the policy is 60 days.
Whether there will be a new policy is uncertain. But at present, the latest policy release time in Hunan is 20 1 1 year 1 month. More information can be found in hunan food and drug administration.
The above contents are for reference only.
The content is provided by Changsha Gai Shi Jun Bao!
I hope it helps you!
According to the "Measures for the Supervision and Administration of Medical Device Management", three types of medical device business licenses need to be handled in local cities and jurisdictions. It is recommended to log on to the website of the Food and Drug Administration of the Municipal Bureau and check the service guide, which has a detailed introduction.